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Randomized Controlled Trial
. 2020 Jan;8(1):8-23.e18.
doi: 10.1016/j.jvsv.2019.03.023.

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

Susan R Kahn  1 , Jim A Julian  2 , Clive Kearon  3 , Chu-Shu Gu  2 , David J Cohen  4 , Elizabeth A Magnuson  5 , Anthony J Comerota  6 , Samuel Z Goldhaber  7 , Michael R Jaff  8 , Mahmood K Razavi  9 , Andrei L Kindzelski  10 , Joseph R Schneider  11 , Paul Kim  12 , Rabih Chaer  13 , Akhilesh K Sista  14 , Robert B McLafferty  15 , John A Kaufman  16 , Brandt C Wible  17 , Morey Blinder  18 , Suresh Vedantham  19 ; ATTRACT Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

Susan R Kahn et al. J Vasc Surg Venous Lymphat Disord. 2020 Jan.

Abstract

Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.

Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.

Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.

Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Trial registration: ClinicalTrials.gov NCT00790335.

Keywords: Catheter-directed thrombolysis; Deep venous thrombosis; Femoral-popliteal DVT; Iliofemoral DVT; Proximal DVT; Quality of life; Randomized trial.

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Figures

Figure 1:
Figure 1:
CONSORT diagram for participants in QOL analyses
Figure 2:
Figure 2:
VEINES-QOL model-fitted change scores (Baseline to 24 months) treatment effects within subgroups. SE, standard error; CI, confidence interval
Figure 3:
Figure 3:
LOESS-smoothed estimates of the model-predicted VEINES-QOL mean change-from-baseline scores at each assessment for the 4 groups defined by extent of DVT and treatment arm. IF, iliofemoral DVT; FP, isolated femoral-popliteal DVT
Figure 4.
Figure 4.
VEINES-QOL Incremental Change by Group (Model-fitted Estimates). IF, iliofemoral DVT; FP, isolated femoral-popliteal DVT
See this image and copyright information in PMC

Comment in

References

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